Regulatory update: GSK and XenoPort submit supplemental new drug application to FDA

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Posted: 9 August 2011 | | No comments yet

GSK and XenoPort, Inc. request approval of Horizant™…

GlaxoSmithKline (NYSE and LSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) announced today that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) requesting approval of Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the management of postherpetic neuralgia (PHN) in adults.

The sNDA has been submitted to the FDA by GSK.

Related organisations

Food and Drug Administration (FDA), XenoPort Inc.

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Regulatory update: GSK and XenoPort submit supplemental new drug application to FDA

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